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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K120474
Device Name GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY
Applicant
Gyrus Acmi, Inc.
136 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact GRAHAM BAILLE
Correspondent
Gyrus Acmi, Inc.
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact GRAHAM BAILLE
Regulation Number880.6850
Classification Product Code
KCT  
Date Received02/16/2012
Decision Date 07/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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